Navigation Links
Statement from the Cystic Fibrosis Foundation on Passage of the EXPERRT Act in House of Representatives
Date:6/20/2012

BETHESDA, Md., June 20, 2012 /PRNewswire-USNewswire/ -- The Cystic Fibrosis Foundation issued the following statement in response to passage of legislation today in the House of Representatives to expand consultation between the Food and Drug Administration (FDA) and external rare disease experts and patient advocates during the FDA drug approval process. 

The bill is known as the Expanding and Promoting Expertise in Review of Rare Treatments Act (EXPERRT). It was introduced by Reps. Edward Markey (D-MA), Tom Marino (R-PA) and Cliff Stearns (R-FL).  EXPERRT passed as part of the Food and Drug Administration Safety and Innovation Act, which reauthorizes the FDA's user-fee program that funds its drug and device evaluation.

"The Cystic Fibrosis Foundation applauds the approval of the EXPERRT Act, which will help expedite the approval of safe and effective new rare-disease drugs and treatments for patients by ensuring that the FDA has the most complete information during its evaluation," said Robert J. Beall, Ph.D., president and CEO of the Cystic Fibrosis Foundation. "This legislation is critically important to the 30,000 Americans with cystic fibrosis and millions more with rare diseases who desperately need access to sophisticated therapies for their complex conditions. We extend our special thanks to Representatives Markey, Marino and Stearns for the critical work they have done to advance this legislation."

"The inclusion of the EXPERRT Act in the FDA Safety and Innovation Act ensures that sharing knowledge amongst the FDA and individuals with expertise in rare diseases will become common practice," said Markey, co-chair of the Congressional Cystic Fibrosis Caucus. "Information about the severity of diseases, the risks patients may be willing to take, or improved clinical trial designs will help facilitate the review process and bring new treatments for rare diseases like cystic fibrosis to market quicker and more easily."'/>"/>

SOURCE Cystic Fibrosis Foundation
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. Millennium Laboratories Wins Lawsuit: Ameritox Advertisements Regarding Rx Guardian and Rx Guardian CD Contain Literally False Statements
2. American Society of Hematology Statement on House Passage of Prescription Drug User Fee Act (PDUFA)
3. American Society of Hematology Statement on Senate Passage of Prescription Drug User Fee Act (PDUFA)
4. Icahn Issues Statement Regarding Amylin Pharmaceuticals
5. Savara Pharmaceuticals Completes Phase I Clinical Study of AeroVanc in Cystic Fibrosis Patients
6. Top-line Data From Phase 3 Trial of Ataluren in Patients with Nonsense Mutation Cystic Fibrosis Show Promising Results
7. Insmed Incorporated Announces Lifting of Clinical Hold by U.S. Food and Drug Administration on ARIKACE® in Cystic Fibrosis Patients With Pseudomonas Lung Infections
8. Synteract and Rempex Partner in "Great Strides" Walk to Support Cystic Fibrosis Cure
9. Cell Therapeutics to Host Investor and Analyst Meeting to Discuss Targeted Agents in Myelofibrosis and High-Risk Myelodysplastic Syndrome/Acute Myeloid Leukemia on Sunday, June 3, 2012, in Chicago
10. Gateway Foundation Warns K2 is Bad News: K2 Poses Serious Health Risks
11. AUA Foundation Launches Campaign to Address Stigma of Overactive Bladder
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/29/2014)... DUBLIN , Aug. 29, 2014 ... the "Research and Development Trend Forecast of Pharmaceutical ... offering. Research and Development Trend Forecast ... , 2014-2018 mainly analyzes China,s ... status, supply & demand, competition landscape, and business performance ...
(Date:8/29/2014)... YORK, Pa. , Aug. 29, 2014  Unilife ...  ASX: UNS) announced today that it intends to release ... and year ended June 30, 2014 after market trading ... Management has scheduled a conference call for 4:30 p.m. ... 10, 2014 at 6:30 a.m. AEST), to review the Company,s ...
(Date:8/29/2014)... , Aug. 29, 2014  Pacific Medical Data ... new website design . The main website, along ... showcases the company,s new services and content relevant to ... a new streamlined design, viewers can now better understand ... health care practices and create a more visible platform ...
Breaking Medicine Technology:Research and Development Trend Forecast of Pharmaceutical Equipment Market in China, 2014-2018 2Unilife Corporation to Announce Financial Results for Fiscal Year 2014 Fourth Quarter and Year End on Tuesday, September 9, 2014 2PMDS Announces New Website 2
... Pa., March 16, 2011 Beginning April 1, Highmark ... patients with primary immunodeficiency diseases (PIDD) and other rare ... of immunoglobulin (IgG - a blood plasma product), regardless ... "formulary," even patients who are successfully being treated with ...
... 2011 New visits for drug-related poisoning in the ... of Emergency Physicians (ACEP) and the American Association of ... of drug poisoning as part of Poison Prevention Week ... to members of Congress urging them to continue allocating ...
Cached Medicine Technology:New Highmark Policy Threatens Pennsylvania Patients With Primary Immunodeficiency Diseases 2New Highmark Policy Threatens Pennsylvania Patients With Primary Immunodeficiency Diseases 3Drug-Related Poisoning The Cause For Nearly 700,000 Emergency Department Visits a Year, According to New Research 2Drug-Related Poisoning The Cause For Nearly 700,000 Emergency Department Visits a Year, According to New Research 3
(Date:8/30/2014)... Seattle, WA (PRWEB) August 30, 2014 One ... of this era is the gluten-free diet. Originally meant for ... has become a catchall for people who are looking to ... gluten. However, not only is this kind of information erroneous, ... of health problems because of a drastic change in ...
(Date:8/30/2014)... LiveStreamingFitness.com, a company dedicated to providing live ... resources, is proud to announce it has been recognized as ... fitness solutions by ABC’s Good Morning America. ... Good Morning America, “Live Streaming Fitness is the hottest new ... by streamlining your workout…to boot camp at Life Streaming Fitness ...
(Date:8/30/2014)... Bellevue, WA (PRWEB) August 30, 2014 “In ... State alone,” The Jones Firm says in a recently released ... , “A person was injured in an auto accident every ... every 16 minutes,” they continue. “Based on the 2013 statistics, ... in a vehicle collision.” , The threat of an auto ...
(Date:8/30/2014)... Boston, MA (PRWEB) August 30, 2014 ... and nurse practitioner locum tenens company , announces ... open September 1, 2014. Barton Associates is headquartered in ... Enfield, CT; Keene, NH; and Jupiter, FL. ... response to the increasing demand for healthcare providers. The ...
(Date:8/30/2014)... Saturday 30 August 2014: The first multidisciplinary recommendations ... acute coronary syndromes (ACS) are published today in ... was written jointly by the European Heart Rhythm ... and the European Association of Percutaneous Cardiovascular Interventions ... Bulent Gorenek (Turkey), chairperson of the task force, ...
Breaking Medicine News(10 mins):Health News:“What is Gluten: Three Things You Need to Know Before Adopting a Gluten-Free Diet” Reveals What Readers Need to Know About the Benefits of a Strict Gluten Diet - Vinamy 2Health News:LiveStreamingFitness.com is New Trend In Fitness 2Health News:Startling Washington Auto Accident Statistics Discussed In Recently Released Article By The Jones Firm 2Health News:Barton Associates Announces New Office Location in Austin, TX 2Health News:First multidisciplinary recommendations on management of arrhythmias in ACS patients 2
... Most American women (57%) want the,First Lady to take ... leader on,issues that are important to her. Relatively few women ... in deference to her,husband, and there is even less support ... partner of the president and involves herself in government,policy and ...
... Dec. 29 Second Harvest Heartland, the,Upper Midwest,s ... with Feeding America, General Mills and NBC,s "The ... every pound participating dieters,in Minnesota and western Wisconsin ... will donate 10 cents to Second Harvest Heartland ...
... magazine has named St. Jude Children,s Research Hospital ... the country. The results, based on the magazine,s survey ... February 2009 issue on newsstands nationwide January 13, 2009. ... of Children,s Hospitals and Related Institutions, an organization of ...
... new study examining the aftereffects of a chlorine gas disaster ... insight into what to expect and how to prepare emergency ... potentially deadly gas. The study is now available in the ... Medicine . , "This is one of the largest ...
... While older large series of patients with hepatic granulomas ... common causes of hepatic granulomas, recent works have noted ... and no other obvious associations. Today, patients that undergo ... being staged prior to possible anti viral therapy. The ...
... highly prevalent in different geographic populations and cause ... of those affected. Examples include GERD, uninvestigated dyspepsia, ... have an impact on the individual,s quality of ... evaluating the impact of chronic gastrointestinal symptoms on ...
Cached Medicine News:Health News:YWCA Survey Reveals Women Want a Modern First Lady 2Health News:Second Harvest Heartland, Feeding America, General Mills, and 'The Biggest Loser' Team to Help Community Lose Weight and Raise Funds to Feed the Hungry 2Health News:Second Harvest Heartland, Feeding America, General Mills, and 'The Biggest Loser' Team to Help Community Lose Weight and Raise Funds to Feed the Hungry 3Health News:Second Harvest Heartland, Feeding America, General Mills, and 'The Biggest Loser' Team to Help Community Lose Weight and Raise Funds to Feed the Hungry 4Health News:St. Jude Ranked No. 1 Pediatric Oncology Hospital in National Magazine Survey 2Health News:New study examines effects of Graniteville, S.C., chlorine gas disaster 2Health News:New study examines effects of Graniteville, S.C., chlorine gas disaster 3Health News:May hepatic granulomas be part of the histological spectrum of chronic hepatitis C? 2Health News:Chronic gastrointestinal symptoms in Korean population 2
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
Medicine Products: